PMID- 23056564
OWN - NLM
STAT- MEDLINE
DCOM- 20130531
LR  - 20220309
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 7
IP  - 10
DP  - 2012
TI  - Adverse events of pirfenidone for the treatment of pulmonary fibrosis: a 
      meta-analysis of randomized controlled trials.
PG  - e47024
LID - 10.1371/journal.pone.0047024 [doi]
LID - e47024
AB  - BACKGROUND: Pirfenidone (PFD) is a novel antifibrotic agent approved for patients 
      with pulmonary fibrosis. However, there are concerns regarding toxicity of the 
      drug. In this meta-analysis, we analyzed the adverse events (AEs) of PFD for the 
      treatment of pulmonary fibrosis. METHODS: We performed a systematic search of 
      PubMed, Embase, ClinicalTrials.gov, and Cochrane Central Register of Controlled 
      Trials for trials published between January 1999 and October 2011. Data extracted 
      from literature were analyzed with Review manager 5.0.24. RESULTS: The results of 
      six randomized controlled trials (1073 participants) revealed that the number of 
      individuals who discontinued PFD therapy was significantly higher than patients 
      receiving placebo. The PFD group had a significantly higher rate of 
      gastrointestinal (nausea, dyspepsia, diarrhea, and anorexia), neurological 
      (dizziness and fatigue), and dermatological (photosensitivity and rash) AEs 
      compared to the placebo group. CONCLUSIONS: PFD used for the treatment of 
      pulmonary fibrosis is not so safe or well-tolerated. Notably, gastrointestinal, 
      neurological and dermatological adverse effects were more common in patients 
      receiving PFD therapy, and therefore appropriate precaution is needed.
FAU - Jiang, Chunguo
AU  - Jiang C
AD  - Department of Respiratory Medicine, Peking Union Medical College Hospital, 
      Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 
      China.
FAU - Huang, Hui
AU  - Huang H
FAU - Liu, Jia
AU  - Liu J
FAU - Wang, Yanxun
AU  - Wang Y
FAU - Lu, Zhiwei
AU  - Lu Z
FAU - Xu, Zuojun
AU  - Xu Z
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20121009
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Pyridones)
RN  - D7NLD2JX7U (pirfenidone)
SB  - IM
MH  - Humans
MH  - Pulmonary Fibrosis/*drug therapy
MH  - Pyridones/*adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic
PMC - PMC3467250
COIS- Competing Interests: The authors have declared that no competing interests exist.
EDAT- 2012/10/12 06:00
MHDA- 2013/06/01 06:00
PMCR- 2012/10/09
CRDT- 2012/10/12 06:00
PHST- 2012/05/26 00:00 [received]
PHST- 2012/09/07 00:00 [accepted]
PHST- 2012/10/12 06:00 [entrez]
PHST- 2012/10/12 06:00 [pubmed]
PHST- 2013/06/01 06:00 [medline]
PHST- 2012/10/09 00:00 [pmc-release]
AID - PONE-D-12-15223 [pii]
AID - 10.1371/journal.pone.0047024 [doi]
PST - ppublish
SO  - PLoS One. 2012;7(10):e47024. doi: 10.1371/journal.pone.0047024. Epub 2012 Oct 9.